Background and Overall Project Objectives.
Group B Streptococcus (GBS) is a leading cause of neonatal infection in Europe, and increasingly recognised as a significant cause of neonatal infection in Sub-Saharan Africa. Over 319,000 infant cases are estimated to occur globally each year. GBS also accounts for 33,000 cases of disease in pregnant or post-partum women, 57,000 stillbirths and 90,000 infant deaths – more than the total number of deaths from mother-to child transmission of HIV and more than the combined neonatal deaths from tetanus and pertussis.
Work Package 1
Project management, scientific coordination & capacity building
Ensure conduct of all research activities to the highest standards, including oversight and coordination of the other Work Packages to ensure deliverables and milestones are met. In addition, the South-South collaboration will oversee all Ugandan site capacity building activities.
Work Package 2
Clinical trial site development and GBS disease surveillance
Establish the GBS disease incidence in an urban Ugandan cohort of 70,000 women and their infants followed from birth to 3 months of age and establish the baseline rates of common adverse obstetric and neonatal outcomes in preparation for Work Packages 4 and Work Packages 5. In conjunction with an MRC-funded clinical trial, establish the infrastructure, expertise and capacity needed for the clinical vaccine trial programmes in PREPARE (Work Packages 4 & Work Packages 5), but also for one that will extend beyond the life of this project.
Work Package 3
Developing serocorrelates of protection against GBS
Develop a biobank of prospectively collected sera from cases of GBS disease and associated GBS disease isolates from a network of African (Uganda, Malawi, South Africa) and European sites (UK, Italy, France, Netherlands) in order to define serocorrelates of protection against GBS using standardised antibody assays.
Work Package 4
Clinical trial in Uganda
A placebo controlled clinical study investigating the safety and immunogenicity of GBS6 vaccine in pregnant women with and without human immunodeficiency virus (HIV) infection and their infants.
Work Package 5
Clinical trial in Uganda and South Africa
The safety and reactogenicity of the GBS-NN/NN2 vaccine compared with placebo in pregnant women. Whether pregnant women with HIV have lower antibody levels following immunisation with GBS-NN/NN2 vaccine than HIV-negative women.
Work Package 6
Communications, networking and dissemination
There are four main areas of activity in this work package:
1. Patient and Public Involvement (PPI)
2. Communications capacity strengthening
3. Stakeholder engagement: internal and external
4. Communication and dissemination of outputs and results, including training on communications for researchers.
These activities link closely with the other work packages, informing their conduct and then communicating their results and outputs.
In addition, we will undertake focus groups and key informant interviews to explore themes around vaccine acceptance and clinical trials.